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Displaying 81 - 100 of 599
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100951-PIP01-23-M01 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100951-PIP01-23-M02 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Rukobia 600 mg prolonged-release tablets
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100235-PIP01-21-M02 (update)
  • Sotrovimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Xevudy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100440-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • BICTEGRAVIR
  • Treatment of Human immunodeficiency virus (HIV) infection
  • Biktarvy
  • Biktarvy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100083-PIP01-21-M01 (update)
  • Human Fibrinogen (INN) / Human Thrombin (INN)
  • HUMAN THROMBIN
  • HUMAN FIBRINOGEN
  • Treatment of: haemorrhage from a surgical procedure
  • CSF leakage from a neurosurgical procedure
  • EVICEL, Solution for sealant
  • EVARREST, Sealant matrix (withdrawn EU MAA)
  • EVICEL
  • EVICEL
  • EVICEL
  • Other: blood-derived topical haemostats
PM: decision on the application for modification of an agreed paediatric investigation plan. No 15/11/2021
MHRA-100081-PIP01-21
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Other: Renal Disease
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021
MHRA-100060-PIP01-21
  • 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/03/2022
MHRA-100330-PIP01-21
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Other: Metabolic disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100162-PIP01-21-M01 (update)
  • SELEXIPAG
  • Treatment of pulmonary arterial hypertension (PAH)
  • Uptravi
  • Uptravi
  • Uptravi
  • Other: Pulmonary heart disease and diseases of pulmonary circulation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100035-PIP01-21
  • POVIDONE-IODINE
  • ISOPROPYL ALCOHOL
  • Prevention of infection prior to invasive procedures
  • PurPrep
  • Other: Antiseptic
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
MHRA-100284-PIP01-21-M01 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100025-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of malignant neoplasms of the central nervous system
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/11/2021
MHRA-100173-PIP01-21
  • PACLITAXEL
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100174-PIP01-21
  • Encequidar
  • Treatment of breast cancer
  • Treatment of soft tissue sarcoma
  • Paxorlea
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/11/2021
MHRA-100049-PIP01-21-M01 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/11/2021
MHRA-100024-PIP01-21-M01 (update)
  • LAROTRECTINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100092-PIP01-21-M01 (update)
  • VENETOCLAX
  • Haematopoietic and lymphoid malignant neoplasms
  • Treatment of solid tumour malignant neoplasms
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 03/12/2021
MHRA-100152-PIP01-21
  • cosibelimab
  • Treatment of cutaneous squamous cell carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/12/2021
MHRA-100131-PIP01-21
  • ATEZOLIZUMAB
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021